Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift
Information source: Nguyen, Davis B., M.D.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant
Intervention: Fibrin Sealant (Artiss) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Nguyen, Davis B., M.D. Official(s) and/or principal investigator(s):
Davis B Nguyen, M.D., Principal Investigator, Affiliation: Davis B Nguyen, M.D.
Overall contact:
Davis B Nguyen, MD, Phone: 310 550 0288, Email: nguyendavisb@yahoo.com
Summary
The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in
reducing the incidence of early postoperative bruising and swelling.
Clinical Details
Official title: A Randomized, Controlled Study to Evaluate Safety and Efficacy of Fibrin Sealant VH S/D 4 S-APR (Artiss) for Tissue Adherence and Hemostasis and To Improve Wound Healing in Subjects Undergoing Endoscopic Browlift
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Comparison of ecchymosis and edema
Secondary outcome: Resolution of ecchymosis and edema, incidence of hematoma/seroma
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects planned for endoscopic browlift, subjects who read, understand and sign the
written informed consent, healthy female or male subjects, 18-75 years old, and
subjects who are able and willing to comply with the protocal requirements
Exclusion Criteria:
- Subjects who had previous browlift, subjects indicated for concurrent facial
surgeries, subjects considered to be active smokers, subjects with ecchymosis/edema
on day 0, significant laboratory abnormalities, subjects with known bleeding or
coagulation disorders, subjects treated with anti-coagulants.
Locations and Contacts
Davis B Nguyen, MD, Phone: 310 550 0288, Email: nguyendavisb@yahoo.com
Davis B Nguyen, M.D., Beverly Hills, California 90212, United States; Recruiting
Davis B Nguyen, M.D., Phone: 310-550-0288, Email: nguyendavisb@yahoo.com
Additional Information
Starting date: December 2010
Last updated: March 19, 2011
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